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Home > "A" Clinical Trials Conditions > Acitretin in Treating Patients With Skin Disease or Skin Cancer  Acitretin in Treating Patients With Skin Disease or Skin Cancer
Acitretin in Treating Patients With Skin Disease or Skin Cancer
For Condition: actinic keratosis,squamous cell carcinoma of the skin,stage 1 mycosis fungoides/Sezary syndrome,skin metastases,stage 4 mycosis fungoides/Sezary syndrome,basal cell carcinoma of the skin,stage 3 mycosis fungoides/Sezary syndrome,stage 2 mycosis fungoides/Sezary syndrome
Status: No longer recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Acitretin may be an effective treatment for skin disease and skin cancer. PURPOSE: Phase II trial to study the effectiveness of acitretin in treating patients who have skin disease or skin cancer.
Details: OBJECTIVES: I. Determine the long-term safety and efficacy of acitretin in patients with psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas, or other retinoid-responsive diseases or malignancies. PROTOCOL OUTLINE: Patients receive oral acitretin daily in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of psoriasis, cutaneous disorders of keratinization, or other retinoid-responsive disorders or malignancies OR Diagnosis of multiple basal cell carcinomas resulting from one of the following: Nevoid basal cell carcinoma syndrome; Xeroderma pigmentosum; Arsenical insecticide exposure; Sunlight exposure X-irradiation - Widespread involvement (e.g., psoriasis involving 10% or more of body surface area OR Severe, recalcitrant localized involvement (e.g., keratoderma palmaris et plantaris) - Female patients must have disease that is severe and recalcitrant to all other standard therapies --Prior/Concurrent Therapy-- - No chronic intake of excessive vitamin A exceeding 25,000 IU/day --Patient Characteristics-- - Age: Any age - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: No persistently abnormal liver function tests; SGOT or SGPT no greater than 3 times upper limit of normal (ULN) - Renal: No persistently abnormal renal function tests; Creatinine no greater than 3 times ULN - Other: No persistent pretreatment hypertriglyceridemia (greater than 300 mg/dL); No significant neurological, musculoskeletal, or other internal medical disorder that would preclude retinoid therapy; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 years after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnDiGiovanna, Study Chair, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Intramural Research Program
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: CDR0000068733; NCI-77-AR-0172
Study Start Date: December 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020956
Other Basal Cell Carcinoma Of The Skin Studies:
1. Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
2. Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
3. Acitretin in Treating Patients With Skin Disease or Skin Cancer
4. Green Tea Extract in Treating Patients With Actinic Keratosis
5. Celecoxib in Preventing Skin Cancer
Related Studies:
Other basal cell carcinoma of the skin Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Acitretin in Treating Patients With Skin Disease or Skin Cancer
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